Control of vagal stimulation
Inventors
Levine, Jacob A. • Faltys, Michael A. • Simon, Jesse M.
Assignees
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Publication Number
US-12121726-B2
Publication Date
2024-10-22
Expiration Date
Abstract
Methods and apparatuses for stimulation of the vagus nerve to treat inflammation including adjusting the stimulation based on one or more metric sensitive to patient response. The one or more metrics may include heart rate variability, level of T regulatory cells, particularly memory T regulatory cells, temperature, etc. Stimulation may be provided through an implantable microstimulator.
Core Innovation
The invention concerns systems and computer-implemented methods for treating inflammation using vagus nerve stimulation applied to a cholinergic anti-inflammatory pathway (NCAP). An implantable microstimulator applies neural stimulation, and an external programmer communicates with the implantable microstimulator. Patient metrics and/or physiological metrics are used to determine responder status and to adjust stimulation parameters and dosing delivered by the implantable microstimulator.
A key finding is that, in responders, vagus nerve stimulation can increase memory T regulatory cells (mTregs). The approach includes correlations between mTreg increases and improved clinical scores including ACR and EULAR, with inflammation context including regulatory T cells (Tregs) and cytokines. The system supports closed-loop or semi-closed-loop control concepts where patient metric data can drive dosing and parameter adjustments.
The system also includes user-interface control features for stimulation parameters and dosing management, including delaying, postponing, or canceling doses with safety mechanisms such as an emergency stop. Pairing between the external programmer and the implantable microstimulator is confirmed before transmitting user input. In implementations, monitoring may include sensing physiological signals and other metrics integrated with the stimulation control framework.
Claims Coverage
The partial set includes three independent claims: clm-00001 (system for treating inflammation with external programmer pairing and user interface for stimulation/dosing), clm-00012 (similar system with emergency stop provision), and clm-00013 (method using a user’s mobile device where delaying dosing can occur when the programmer is not in communication). Across the independents, the claims emphasize implantable microstimulator stimulation of NCAP, external programmer pairing and indirect transmission of user input, and user-interface-driven parameter adjustment and dosing delay plus, in one claim set, emergency stop directly transmitted to the implant.
NCAP neural stimulation with implantable microstimulator
An implantable microstimulator configured to apply neural stimulation to a cholinergic anti-inflammatory pathway (NCAP).
External programmer communication with implantable microstimulator
An external programmer configured to communicate with the implantable microstimulator.
Paired indirect transmission of user input for stimulation parameters and dosing
Presenting a user interface for adjusting stimulation parameters; receiving user input for adjusting or delaying dosing; confirming that the external programmer is paired with the implantable microstimulator before transmitting the user input; and transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
Emergency stop received and directly transmitted to the implant
Receiving an emergency stop and directly transmitting the emergency stop to the implantable microstimulator.
Mobile-device user interface with delayed dosing input when programmer is not communicating
Presenting a user interface for adjusting stimulation parameters on the user’s mobile device; receiving, through the user interface, user input for delaying dosing or adjusting stimulation parameters, wherein the user input for delaying dosing is received when the external programmer is not in communication with the implantable microstimulator; confirming pairing of the external programmer with the implantable microstimulator; transmitting the user input indirectly to the implantable microstimulator through the external programmer when paired; and adjusting the implantable microstimulator based on the user input.
Overall, the claim coverage centers on an NCAP-treated inflammation system using an implantable microstimulator coordinated with an external programmer, where a paired, indirectly transmitted user input updates stimulation parameters and dosing, including delayed dosing. One independent claim further requires an emergency stop received and directly transmitted to the implant, and another independent claim includes a mobile-device user interface where delaying dosing input is received when the external programmer is not in communication.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating inflammation using vagus nerve stimulation applied to a cholinergic anti-inflammatory pathway (NCAP) and using patient metrics to determine responder status and correlate outcomes with clinical scores including ACR and EULAR.
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